HILL-ROM #840

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-02-08 for HILL-ROM #840 manufactured by Hill-rom.

Event Text Entries

[1802] On january 8, 1993, at approximately 9:30 p. M. , the post si=urgical patient in room 3147 called the nurse. This patient was on bed rest at 45 degree upright position and called the nurse to complain that while asleep, the bed lowered to horizontal position all by itself. Upon examination by the physician, the patient ws presented with broken sutures and oozing blood from surgical area which required immediate surgical intervention. Although this incident was unwitnessed, the hillrom bed was immediately removed from the patient care area and sent to maintenance for repair. The maintenance engineer assigned to repairing all beds from the patient care areas discovered that not just one but, two of the hill rom 840 beds had electrical problems in the head controldevice not labeled for single use. Patient medical status prior to event: invalid data. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced:. Service provided by: user facility biomedical/bioengineering department. Service records available. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: invalid data. Results of evaluation: component failure. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device repaired and put back in service. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2534
MDR Report Key2534
Date Received1993-02-08
Date of Event1993-01-08
Date Facility Aware1993-01-10
Date Reported to Mfgr1993-01-10
Date Added to Maude1993-03-11
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameHILL-ROM
Generic NamePATIENT BED
Product CodeFNK
Date Received1993-02-08
Model Number#840
Catalog Number#840
Device Availability*
Device Age01-SEP-80
Implant FlagN
Device Sequence No1
Device Event Key2357
ManufacturerHILL-ROM


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 1993-02-08

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